ES2573509T3 - Cassette and system component insertable in a centrifuge in conjunction with the cassette - Google Patents

Abstract

A cassette (2) comprising a product transport path (1, 1a, 1b) and positioning means (3a, 3b) that can be coupled with a counter piece in a centrifuge having a rotor for separating blood components or in a system component (4) installed in a centrifuge such that a section of the product transport path (1, 1a, 1b) is aligned with a section of the centrifuge or the system component installed in the centrifuge , in which a tube connected with bags is accommodated in the product transport path (1, 1a, 1b), characterized in that the positioning means (3a, 3b) are provided in the form of a plurality of bars (3a, 3b) installed in the direction of one or more sections of the product transport path (1, 1a, 1b) and the bars are installed in a window (17).

Description

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DESCRIPTION

Cassette and system component insertable in a centrifuge in conjunction with the cassette

The invention relates to a cassette used as a cover to accommodate blood bags for a cartridge of a centrifuge to separate the components from the blood.

In transfusion medicine, the so-called blood component therapy has been established since the early 1990s. This means that, instead of preserving whole blood, only the required blood components are administered to an individual patient. for said patient. This separate administration of the individual blood components makes it possible for an individual blood reserve to optimally help an average of 1.8 patients.

The essential components of blood are:

The red blood cells in the so-called erythrocyte concentrate, of which the transfusion is done in order to maintain the oxygen supply after a severe loss of blood,

Blood platelets in the thrombocyte concentrate, which are administered in cases of coagulation problems (hemophilia), and

The blood plasma which is administered in cases of coagulation problems and volume deficit.

Apart from those, blood plasma is an essential basic component for the production of many medications.

In the separation of the individual components of the blood, which is defined as a separation / isolation of cells, it is known to be effected by treating the blood in a centrifuge. By centrifugation, the individual blood components are separated from each other and can then be filled separately in respective containers for later use.

Documents DE 10 2007 000 308 A1, DE 10 2007 000 309 A1 and DE 10 2007 000 310 A1 already disclose a cartridge for use in a centrifuge to separate the blood components in a respective centrifuge as well as a respective procedure. According to these documents, a cartridge comprises an intermediate wall and a cover. The intermediate wall separates an area of the bag of blood arranged radially inside from a product area arranged radially outside. In a cartridge installation position, the cover is placed above the area of the blood bag. The cover is connected to the intermediate wall in an articulated way at one point and so that it can be detached at a second point. In this way, the area of the blood bag is freely accessible by a lateral turning of the cover. To load the cartridge with a blood bag, the cover is opened, a blood bag and a bag of the products are inserted into the respective chambers and a connection tube is inserted along a product transport path . In addition, photosensitive sensors are installed along the product's transport path and are used to establish the composition of the product while obtaining the product; When a specific composition is reached, measures are taken to finish obtaining the product. However, loading of the cartridge can only be done manually, which makes it time consuming and expensive. In addition, there is a possibility that the product will be destroyed at the time of a defective insertion of the connection tube, because the sensors do not react in time.

A cassette that has positioning means that can be coupled with a counter part in a system component is known from US 5 795 317.

Therefore, the known means need to be improved in such a way that, on the one hand, a defective load is avoided and, on the other hand, time is saved, and it is the object of the invention to provide a cassette that meets these requirements. The object of the invention is achieved by means of a cassette according to claim 1. Advantageous embodiments are carried out according to the dependent claims.

According to the present disclosure, a cassette is provided comprising a transport path of the product in the form of a passage and a positioning means that can be coupled with a counter part in a centrifuge or in a system component installed in a centrifuge of such so that a section of the product transport path is aligned with a section of the centrifuge or system component installed in the centrifuge. A tube connected with bags fits into the product's transport path.

Therefore, cassettes with the tube already inserted and two or more bags (a bag of blood and at least one bag of the product) attached to the tube can be supplied to a user in the form of a set. Therefore, after a blood collection process, the cassette comprising the tube and the bags can be inserted inside

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a system component of a centrifuge or directly inside the centrifuge to perform a centrifugation process in which the blood in a bag is separated and at least one of the components of the separated blood is transferred into the second bag.

After this centrifugation process is complete, it is merely necessary to replace the cassette present in the centrifuge with a new one and subject the old cassette to further processing. In this respect it is observed that, in general, any number of cassettes can be subjected to the centrifugation process. Preferably a number of six cassettes are processed simultaneously in the centrifuge.

Since the tubes and bags are replaced together with their related cassette, a noticeable reduction in downtime is achieved.

The exact alignment of the connection means with the counter part makes it possible to achieve an exact alignment of the product transport path with the respective section of the centrifuge or the system component. This ensures that the photosensitive sensors installed in the system component section can detect the product flowing through the product's transport path at any time. Therefore, appropriate reactions, for example to terminate the production process, are possible immediately, without delays. In particular, the section of the product transport path and / or the pipe installed directly adjacent to the installation means can be placed exactly so that they are directly adjacent to the counter piece where the sensors are provided. Additionally, due to the positioning means, it is ensured that an axis of the sensors intersects substantially with a central axis of the product transport path at a right angle.

Advantageously, the cassette can consist of a lower part an upper part which are connected to each other by means of pressure elements or other means. It is also possible that the positioning means is only formed in the lower part, only in the upper part, or both. Other means in terms of the invention may be for example threaded joints and / or joints with rivets or adhesion joints.

According to the invention, the positioning means is provided in the form of one or several bars installed in the direction of one or more sections of the product transport path. The bars are installed in a window. An installation of this type can be easily fabricated and a connection can be easily established in the form of an adjustment with a properly formed counter part.

Advantageously, the at least one closing device for interrupting a product flow can be additionally provided in one or more sections of the product transport path. The closing device performs an abrupt termination of the possible production process. The maximum possible part of the desired product, for example thrombocytes, can be won before the product is contaminated by unwanted components of the blood.

Advantageously, the at least one closing device can be integrated in the lower part or in the upper part of the cassette and can be operated directly from outside the cassette. This allows a fast and safe operation of the closing device without the danger of a failure, which could otherwise occur due to a defective insertion of the closing device. The closing device can be operated manually or mechanically, for example by means of pneumatically, hydraulically or electronically driven actuators.

Advantageously, the at least one closing device can be provided in the form of one or two tube clamps, which can be operated separately from each other. In addition, the cassette can comprise connection means to be connected to a cartridge, which can be accommodated in the centrifuge or in the system component installed in the centrifuge. Accordingly, the cassette performs a function as a cartridge cover.

Advantageously, the cassette according to the invention is accommodated in a system component for installation in a centrifuge for the separation of blood components, with a rotating rotor around a hub. The system component comprises a counter part which can be coupled with a cassette positioning means. In this way, an exact placement of a section of the product's transport path is ensured.

The counter piece may be provided in the form of an elevation having one or more grooves in the sections of the wall in which one or more sensors are installed. Preferably, these are photosensitive sensors / photo sensors.

Additionally the component the system may comprise a drive means for operating a locking device arranged in the cassette. It may preferably be provided in the form of a centrally installed lever that has two ends and two L-shaped short levers installed.

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at the ends of the long lever. Each end of the long lever can be operated directly by a first piston or indirectly by a second piston and a short L-shaped lever leg.

Preferably, the cassette and system component can be used in a centrifuge for the separation of blood components, which has a rotor of a spinning centrifuge around a bucket. The system component is accommodated in the rotor or integrated into it. In addition, a cartridge may be incorporated into the system component and this cartridge may be provided with a cassette loaded with a blood bag and a product bag. The cassette is used as a cover for an area of the cartridge's blood bag.

The use of a cassette according to the invention and the system component allows one or several products of the blood to be obtained, such as plasma, erythrocytes, or thrombocytes. This can be obtained particularly because a microprocessor may be provided in the system component to be used to control and monitor the product extraction process.

Then, by means of the microprocessor, particularly the results of the detection of the sensors can be processed and the actuations of the closing devices can be carried out accordingly. Advantageously, the microprocessor in the system component may additionally be connected to another microprocessor accommodated in the centrifuge rotor, which is adapted to carry out the control and supervision of the entire product extraction process.

Additional advantages of the invention can be seen from the description of a presently preferred embodiment and the attached figures. With reference to the figures:

Figure 1 shows a top view of a lower part of a cassette according to the invention;

Figure 2 shows a sectional view along line II-II of Figure 1;

Figures 3a and 3b show a view from above and a view of a detail III of Figure 1, respectively;

Figure 4 shows a sectional view along the line IV-IV of Figure 1;

Figure 5 shows a top view of an upper part of a cassette according to the invention;

Figure 6 shows a sectional view along line VI-VI of Figure 5;

Figure 7 shows a sectional view along line VII-VII of Figure 5;

Figure 8 shows a view of the cassette according to the invention, said cassette being provided in a system component according to the invention.

A presently preferred embodiment of the invention is described by means of Figures 1 to 8.

A cassette 2 according to the embodiment consists of a lower part 5 and an upper part 7 which are connected to each other by means of pressure elements 9 and 13, and 11 and 15, respectively. The upper part is made of a transparent material. Furthermore, as can be seen from the figures, the cassette 2 is provided approximately in the form of a rectangle having two arms 35a, 35b.

The lower part 5 as well as the upper part 7 of the cassette 2 comprises a window 17 in a central area of the rectangle. In addition, in the upper part 7 two bars 3a, 3b are formed to be used as positioning means according to the invention. The bars 3a, 3b extend along a partial section of a transport path of the product 1.

A passage of the type of channel 1 is formed as a transport path of the product 1 in the lower part 5. Step 1 is divided into two sections 1a and 1b. On one edge of the lower part 5 opposite the arms 35a, 35b, two tube clamps 19a, 19b are integrated into the interior of the lower part 5.

A tube (not shown in the figures) provided with a bag of blood, a filter and a bag of the product are placed in the transport path of the product 1 such that the tube is conducted from the bag of blood arranged between the arms 35a, 35b to the first section 1a, along the bar 3a, through the tube clamp 19a installed in the first section 1a further up to the arm 35a. The tube then emerges from the arm 35a, leads to the filter and enters through the second arm 35b in the second section 1b of step 1. Then, the tube is conducted along the bar 3b, through the clamp of the tube 19b and again the arm 35b, so that it emerges therefrom into the product bag.

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In each of its arms 35a, 35b, the cassette 2 comprises an extension 21a, 21b arranged inside, which is used to fix so that the cassette can be detached from a cartridge not shown similar to that of documents DE 10 2007 000 308 A1, DE 10 2007 000 309 A1 and DE 10 2007 000 310 A1. The blood bag, the filter bag of the product are then accommodated in the appropriate chambers of the cartridge. Cassette 2 replaces a cover in such applications.

Together with cassette 2, the loaded cartridge is inserted into a system 4 component that is installed in a centrifuge. An elevation 25 in which two grooves are formed is provided in a section of the system component 4. Photosensitive sensors 23a, 23b are inserted into the interior walls of each groove.

If the cassette 2 is arranged in the system component 4, the elevation 25 is coupled in a connection in form of adjustment with the window 17 and the bars 3a and 3b with the grooves formed in the elevation 25. The sections of the tube to be they extend along the bars 3a, 3b are arranged directly below the bars 3a, 3b, whereby the contents of the tube can be exactly recorded by the photosensitive sensors 23a, 23b. The first photosensitive sensor 23a is assigned to the first section 1a of the product transport path 1, while the second photosensitive sensor 23b is assigned to the second section 1b of the product transport path 1. The optical axes of the photosensitive sensors 23a and 23b substantially intersect the central axis of the product transport path (the tube) at a right angle.

Since the tube does not have to be inserted inside the cassette 2 anymore, but the cassette is already distributed along with the easily placed tube including the blood bag, the filter and the product bag, a defective insert of the tube or a displacement of the tube that could lead to a faulty registration by the sensors can be reliably excluded.

Therefore, it is possible, due to the cassette interaction according to the invention with the system component, to obtain a blood product by means of the procedure disclosed in DE 10 2007 000 309 A.

According to the embodiment, the centrifuge rotor is designed for six components of system 4 that have one cartridge each. After all the cartridges with the cassettes 2 have been inserted, the centrifuge is started. By means of the centrifugal force, the desired separation of the blood components is effected. Since the "leukocyte layer" diluted by an additive solution is in the blood bag, the lighter components of it will remain radially inside, while the heavier components, that is, the red blood cells, are Pick up abroad.

In order to transport the desired blood component, according to the embodiment, these are high quality platelets (thrombocytes), this is without the mixing of other blood cells, from the blood bag, the separation of the components will be followed by a slight pressure that is applied to the blood bag by means of a pressure pad, so that, after the previously closed tube clamps 19a, 19b have been opened, the solution Platelet-rich begins to rise inside the tube provided in step 1. The platelet-rich solution is conducted through the tube into the filter designed as a leukocyte filter and is further conducted through it.

In the leukocyte filter, unwanted leukocytes, that is, the white blood cells are extracted. Due to the installation of the tube with the filter, the filtering is carried out against the centrifugal force. Therefore, heavier components of the blood, such as unintentionally transported red blood cells, are trapped in a chamber at the entrance of the radially placed outer filter.

After having passed the leukocyte filter, the platelet-rich solution continues to flow through the tube placed in the second section 1b of step 1 into a product bag, in which it is collected. Preferably, the product bag is already formed as a final storage bag for the product.

In order to extract any air that may be present in the filter, the flow rate is kept low for a certain amount of volume at the beginning of the product transfer, thereby allowing the filter to be filled with the blood product reliably and completely. After the transfer of this specific amount of volume, the transport speed for a second specific amount of volume is increased by an appropriate control of the pressure pad. While this second volume is transported, there is hardly any risk that the red blood cells contaminate the blood product (in this case: thrombocyte concentrate). If this nevertheless occurs, this small number of red blood cells are collected in the lower and outer area of the filter, because the tube begins to be guided from the outside radially and below to the inside of the filter and due to the effect of the force centnuga.

After the second volume has been transferred the first sensor photo 23a is activated and the flow rate of the blood product in the tube is reduced.

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When the first sensor photo 23a detects a previously determined proportion of red blood cells in the thrombocyte-rich solution, it emits a signal output by means of which the flow rate is reduced again. Additionally, the second photo sensor 23b disposed behind the filter is activated.

During this phase, a fairly large number of red blood cells can also enter the filter and even pass through it until the second sensor photo 23b detects a previously determined proportion of red blood cells in the product of the blood and emits a signal to finish the cell separation process. By this signal, the tube clamps 19a, 19b are closed by actuating the ends 29a, 29b of a long lever 29 by means of the pistons 31a, 31b, so that the red blood cells in the filter are reliably separated from the thrombocyte concentrate in the product bag.

As an alternative to termination by the second sensor photo 23b, the cell separation process can also be terminated after a certain period of time has elapsed after the activation of the second sensor photo 23b.

In the embodiment, the six cartridges all together are provided in the centrifuge. The control described above in this document of the process of separating cells in a cartridge 1 by means of a pressure pad, the opening and closing of the tube clamps 19a, 19b and the process control by means of the two photo sensors 23a, 23b allows continuous cell separation in the cartridges of the other system components, since the process control described takes place individually for each combination of cartridge and system component.

The process control is carried out by means of a microprocessor provided in the system component, said microprocessor processing the results of the detection / registration of the sensors 23a, 23b and accordingly controlling the opening and closing of the tube clamps 19a, 19b by operating the levers 31a, 31b and 33a, 33b, respectively. In addition, the microprocessor is connected to a microprocessor installed in the rotor hub to control the centrifuge and monitor the microprocessors in the individual system components.

When the aforementioned process is carried out, precise operation of the tube clamps 19a, 19b is required to ensure optimum performance while simultaneously preventing contamination of the product. For the actuation of the tube clamps 19a, 19b integrated in the lower part 5 of the cassette 2, the invention provides, in the system component, an installation having a long lever centrally installed in which nine and short levers, in the form of L 27a, 27b installed at the two ends 29a and 29b of the long lever 29. The ends 29a, 29b of the long lever are arranged between a leg of the short lever 27a, 27b and a closing arm 191 of the clamp of the tube 19a and 19b, respectively.

In its central section, the long lever 29 is fixed to the system component 4. The short levers 27a, 27b are articulated in an articulated manner around the intersection of the two legs of the "L". The installation of the entire lever is arranged along the edge of the cassette 2, in which the tube clamps 19a, 19b are installed when the cassette is inserted inside the system component.

Pistons 31a, 31b, 33a, 33b, which are properly installed in the system component 4, are used to drive the levers 27a, 27b and 29. The pistons 31a, 31b act directly at the respective ends 29a, 29b of the long lever The pistons 33a, 33b act directly on a leg of the short levers 27a and 27b, respectively, said leg being arranged between the pistons 33a and 33b and the respective ends 29a, 29b of the long lever 29.

Since the ends 29a, 29b of the long lever 29 are arranged directly opposite the closing arm 191 of the tube clamps 19a and 19b when the cassette is inserted, a piston drive 31a or 31b leads to the closure of the respective clamp of the tube 19a or 19b. Since, in turn, an actuation of the pistons 33a, 33b acts on a leg of the short levers rotatably held 27a and 27b, respectively, this drive leads to a rotation of the levers 27a and 27b, respectively. The leg arranged between the pistons 33a and 33b acts on the end 29a or 29b of the long lever 29, while the other leg of the short lever 27a or 27b acts on an opening arm 192 of the tube clamp 19a or 19b, opening that way the same. Indirect actuation of the ends 29a, 29b of the long lever serves to exclude that the tube clamp opens explosively too suddenly or too wide, so that problems due to a jam in the tube clamps can be avoided.

The invention has been described by means of a presently preferred embodiment, but is not limited thereto in any way, but is only defined by the scope of the appended claims.

Claims (13)

5 10 fifteen twenty 25 30 35 40 Four. Five fifty 55 60 1. A cassette (2) comprising a product transport path (1, 1a, 1b) and positioning means (3a, 3b) that can be coupled with a counter part in a centrifuge that has a rotor to separate components from blood or in a system component (4) installed in a centrifuge such that a section of the product transport path (1, 1a, 1b) is aligned with a section of the centrifuge or system component installed in the centrifuge, in which a tube connected with bags fits in the product transport path (1, 1a, 1b), characterized in that the positioning means (3a, 3b) are provided in the form of a plurality of bars ( 3a, 3b) installed in the direction of one or more sections of the product transport path (1, 1a, 1b) and the bars are installed in a window (17). 2. A cassette (2) according to claim 1 comprising a lower part (5) and an upper part (7) wherein the installation means (3a, 3b) are formed in the lower part (5) or in the piece superior (7), or both. 3. A cassette (2) according to claim 2 wherein the lower part (5) and the upper part (7) can be connected to each other by a connection means (9, 11, 13, 15) and the Product transport path (1, 1a, 1b) is provided in the form of a step. 4. A cassette (2) according to any one of the preceding claims wherein at least one closing device (19a, 19b) for interrupting a product flow is provided in one with several sections of the product transport path (1 , 1a, 1b). 5. A cassette (2) according to claim 4 wherein the at least one closing device (19, 19b) is integrated inside the lower part (5) or inside the upper part (7) of the cassette. 6. A cassette (2) according to claim 4 or 5 wherein the closing device (19, 19b) is provided with a flange of the cassette and can be operated directly from the outside of the cassette. 7. A cassette (2) according to any one of claims 4 to 6 wherein the at least one closing device (19, 19b) is provided in the form of one or two tube clamps (19a, 19b), which They can be operated separately from each other. 8. A cassette (2) according to any of the preceding claims wherein the cassette comprises connection means (21a, 21b) establishing a connection with a cartridge that accommodates the cassette, said pad being adapted to be accommodated in the centrifuge or in the system component installed in the centrifuge. 9. Blood component separation system comprising a system component (4) to be installed in a centrifuge to separate the blood components, the centrifuge comprising a rotor that can rotate around a bucket and a cassette according to any of claims 1 to 8 wherein the system component (4) comprises a counter part (25) which can be coupled with a means of placement (3a, 3b) of the cassette, wherein the counter part (25 ) is provided in the form of an elevation (25) having one or more grooves in the sections of the wall in which one or more sensors (23a, 23b) are installed and the cassette can be replaced by another cassette. 10. Blood component separation system according to claim 9 further comprising a drive means (27, 29, 29a, 29b, 31, 33) for actuating a closing device (19a, 19b) arranged in the cassette (2 ). 11. Blood component separation system according to claim 10 wherein the actuating means is provided in the form of a centrally installed long lever (29) having two ends (29a, 29b) and two short levers in the form of L (27a, 27b) installed at the ends (29a, 29b) of the long lever, each end (29a, 29b) of the long lever (29) being able to act directly by means of a first piston (31a, 31b) or indirectly by means of a second piston (33a, 33b) and an L-shaped short lever leg (27a, 27b). 12. Blood component separation system according to any of claims 9 to 11 wherein a sensor or several sensors are formed as light sensitive sensors (23a, 23b) and by coupling the positioning means (3a , 3b) of the cassette (2) with a counter piece (25), a central axis of a tube accommodated in the product transport path (1, 1a, 1b) of the cassette (2) exactly aligns with the axis optical or the optical axes of the light sensitive sensor (23a, 23b) or of the light sensitive sensors (23a, 23b). 13. A centrifuge for separating the blood components comprising a rotor that can rotate around a hub, at least one system for separating the blood components according to any of claims 9 to 12, accommodated in the rotor, or integrated therein, a cartridge accommodated in the system component (4) and the cassette loaded with a blood bag and a product bag, in which the cassette is used as a cover for an area of the cartridge's blood bag.